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Marketing Authorisation Holder and Manufacturer

High temperature
Flu type symptoms
Difficulty with speaking
Higher than normal number of white blood cells
(seen by a blood test)
• High levels of liver enzymes in your blood (shown by a
blood test)
• Feeling tired, weak and confused, having muscle that
ache, are stiff or do not work well. There may also be
headache, loss of appetite, nausea or vomiting,
convulsion. This may be due to low sodium levels in
your blood.


Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Molipaxin 150mg Tablets

Fawdon Manufacturing Centre, Edgefield Avenue,
Fawdon, Newcastle upon Tyne, NE3 3TT, UK
This leaflet does not contain all the information about
your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in 07/2013
© Zentiva, 2013

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side
effects directly via the Yellow Card Scheme at:

Take special care with Molipaxin Tablets
Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety disorders you
can sometimes have thoughts of harming or killing
yourself. These may be increased when first starting
antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
- If you have previously had thoughts about killing or
harming yourself.
- If you are a young adult. Information from clinical
trials has shown an increased risk of suicidal
behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an
If you have thoughts of harming or killing yourself at
any time, contact your doctor or go to a hospital
straight away.
You may find it helpful to tell a relative or close
friend that you are depressed or have an anxiety
disorder, and ask them to read this leaflet. You might
ask them to tell you if they think your depression or
anxiety is getting worse, or if they are worried about
changes in your behaviour.

Trazodone hydrochloride
Read all of this leaflet carefully before you start
taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your
doctor or pharmacist.
In this leaflet:
1. What Molipaxin Tablets are and what they are used for
2. Before you take Molipaxin Tablets
3. How to take Molipaxin Tablets
4. Possible side effects
5. How to store Molipaxin Tablets
6. Further information

By reporting side effects you can help provide more
information on the safety of this medicine
5. How to store Molipaxin Tablets
Keep this medicine in a safe place where children
cannot see or reach it.

1. What Molipaxin Tablets are and what they
are used for

Do not use Molipaxin Tablets after the expiry date which
is stated on the blister and carton after EXP. The expiry
date refers to the last day of that month.

The name of your medicine is Molipaxin 150mg Tablets.
(called Molipaxin Tablets in this leaflet). Molipaxin Tablets
contain a medicine called trazodone hydrochloride. This
belongs to a group of medicines called antidepressants.

Store below 30°C
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

Molipaxin Tablets should not be used in children and
adolescents under 18 years of age.
If you are elderly, you may be more prone to side
effects, increased caution is necessary especially when
taking other medicines at the same time as Molipaxin
or if you have some other diseases.

Molipaxin Tablets can be used to treat anxiety and
2. Before you take Molipaxin Tablets

Check with your doctor or pharmacist before taking
this medicine if you:
▲ Have or have ever had fits or seizures
▲ Have severe liver, kidney or heart problems
▲ Are pregnant, trying to become pregnant or are
▲ Have an overactive thyroid gland (hyperthyroidism)
▲ Have problems passing water or need to pass water
(urine ) frequently
▲ Have narrow angle glaucoma (an eye disorder)
▲ Have schizophrenia or other type of mental disorder
▲ Are elderly, as you may be more prone to side effects
If you are not sure if any of the above apply to you, talk
to your doctor or pharmacist before taking Molipaxin

6. Further information
Do not take this medicine and tell your doctor if:
× You are allergic (hypersensitive) to trazodone
hydrochloride or any of the other ingredients of
Molipaxin Tablets (listed in Section 6 Further
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
× You have recently had a heart attack
× You are a heavy drinker or are taking sleeping tablets
× You are under 18 years of age.
Do not take this medicine if any of the above applies to
you. If you are not sure, talk to your doctor or
pharmacist before taking Molipaxin Tablets.

What Molipaxin Tablets contain
• Each Molipaxin 150mg Tablet contains 150mg of the
active substance, trazodone hydrochloride
• Other ingredients include Lactose, calcium hydrogen
phosphate, microcrystalline cellulose, maize starch,
sodium starch glycollate, povidone and magnesium
stearate, hydroxypropyl methyl cellulose, propylene
glycol, red iron oxide (E172) and titanium dioxide
What Molipaxin Tablets look like and contents of
the pack
A salmon pink film-coated tablet with “Molipaxin” and “150”
on one face and a breakline on the other. The tablets are
available in blister packs of 28.



Driving and using machines
Molipaxin Tablets may make you feel sleepy or dizzy. If this
happens do not drive or use any tools or machines.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or
have recently taken any other medicines. This includes
medicines you buy without a prescription, including
herbal medicines. This is because Molipaxin Tablets can
affect the way some other medicines work. Also some
medicines can affect the way Molipaxin Tablets work.

Important information about some of the
ingredients of Molipaxin Tablets
Molipaxin Tablets contain lactose. If you have been told
that you cannot digest or tolerate some sugars, talk to
your doctor before taking trazodone.

Tell your doctor if you are taking any of the
following medicines:
• MAOI (MonoAmine Oxidase Inhibitors) medicine such
as tranylcypromine, phenelzine and isocarboxazid
(for depression) or selegiline (for Parkinson’s disease),
or have taken them in the last 2 weeks
• Other antidepressants (such as amitriptyline or
• Sedatives (such as tranquilizers or sleeping pills)
• Medicines used to treat epilepsy such as carbamazepine
and phenytoin
• Medicines used to treat high blood pressure, for
example, clonidine
• Digoxin (used to treat heart problems)
• Medicines used to treat fungal infections such as
ketoconozole and itraconazole
• Some medicines used to treat HIV such as ritonavir
and indinavir
• Eyrthromycin, an antibiotic used to treat infections
• Levodopa (used to treat Parkinson’s disease)
• St. John’s Wort (a herbal remedy)
• Warfarin (used to stop your blood from clotting)

3. How to take Molipaxin Tablets
Always take Molipaxin Tablets exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Swallow the Tablets whole with a drink of water
• Take with or after food. This can help lower the
chances of side effects
• If you have been told to take Molipaxin Tablets only
once each day then you should take it before going to
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your
How much to take
• Adults usually start by taking 150mg each day
• Your doctor may increase the dose to 300mg
each day depending on your condition
• For adults in hospital the dose may be as high as
600mg each day
• Adults usually start by taking 75mg each day
• Your doctor may increase the dose to 300mg
each day
Older people or those who are frail will usually be
given a starting dose of 100mg each day.
Children and adolescents under 18 years should not
take Molipaxin Tablets.

If you are going to have an anaesthetic (for an
operation), tell your doctor or dentist that you are
taking Molipaxin Tablets.
Taking Molipaxin Tablets with food and drink
You should avoid drinking alcohol while taking
Molipaxin Tablets
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you
are pregnant, might become pregnant, or think you
may be pregnant.
Taking Molipaxin Tablets in the late stages of pregnancy
may lead to your baby experiencing withdrawal
symptoms when they are born.
If you are breast-feeding or planning to breast-feed, talk
to your doctor or pharmacist before taking any medicine.

If you take more Molipaxin Tablets than you should
If you take more Molipaxin Tablets than you should, tell a
doctor or go to a hospital casualty department straight
away. Take the medicine pack with you. This is so the
doctor knows what you have taken.

The following effects may happen: feeling sick or being
sick, feeling sleepy, dizzy or faint, fits (seizures),
confusion, breathing or heart problems.

• Feeling confused, restless, sweating, shaking,
shivering, hallucinations (strange visions or sounds),
sudden jerks of the muscles or a fast heartbeat, you
may have something called Serotonin syndrome
• Feeling very unwell possibly with shortness of breath
(dyspnoea), difficulty in walking or walking with a
shuffling gait, shaking, uncontrolled muscle
twitching, and a high temperature (above 38ºC).
This could be a rare condition known as Neuroleptic
Malignant Syndrome
• Rapid, slow or irregular heartbeat

If you forget to take Molipaxin Tablets
If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the next dose, skip the
missed dose.
Do not take a double dose to make up for a forgotten
If you stop taking Molipaxin Tablets
Keep taking Molipaxin Tablets until your doctor tells
you to stop. Do not stop taking Molipaxin Tablets just
because you feel better. When your doctor tells you to
stop taking these tablets he/she will help you stop
taking them gradually

Below is a list of other side effects that have been
• Feeling drowsy or sleepy, tiredness
• Feeling less alert than usual
• Feeling sick (nausea) or being sick (vomiting),
• Constipation, diarrhoea
• Dry mouth, altered taste, increased amounts of saliva,
blocked nose
• Sweating more than usual
• Dizziness, headache, confusion, weakness, tremor
• Blurred vision
• Loss of appetite and weight loss
• Feeling dizzy or light-headed on standing or sitting
up quickly (postural hypotension), fainting (syncope)
• Feeling restless and having difficulty sleeping
• Water retention which may cause swollen arms or legs
• Skin rash, itching
• Chest pain
• Pain in limbs, back pain, pain in your muscles, pain
in your joints
• Jerking movements that you can not control, mainly
in of the arms and legs, uncontrolled muscle
movements or twitches
• Frequent infections with high temperature, severe
chills, sore throat or mouth ulcers. These could be
signs of a blood problem called leucopenia.
• Feeling anxious or more nervous than usual, feeling
• Overactive behaviour or thoughts (mania), believing
things that are not true (delusions), memory
• Nightmares
• Decreased sex drive
• Feeling dizzy, possibly with a “spinning” feeling (vertigo)
• High blood pressure

4. Possible side effects
Like all medicines, Molipaxin Tablets can cause side
effects, although not everybody gets them.
Stop taking Molipaxin Tablets and see a doctor or
go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips
or throat which may cause difficulty swallowing or
breathing, itching of the skin and nettle rash.
This may mean you are having an allergic reaction to
Molipaxin Tablets.
• Painful erection of the penis, unrelated to sexual
activity, that will not go away (priapism)
• Yellowing of the eyes or skin. This could be a liver
problem (such as jaundice)
• Getting infections more easily than usual. This could
be because of a blood disorder (agranulocytosis)
• Bruising more easily than usual. This could be
because of a blood disorder (thrombocytopenia)
• You have severe abdominal pain and bloating, are
being sick (vomiting) and have constipation. These
may be signs that your intestine is not working
properly (paralytic ilius)
Talk to your doctor straight away if you notice the
following side effects:
• You have thoughts of harming or killing yourself
• Feeling tired, faint dizzy, having pale skin. These
could be signs of anaemeia
• Convulsions/fits
• Unusual skin sensations such as numbness, tingling,
pricking, burning or creeping on the skin

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.